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है”ह”ह

IS 15205 (2002): Oxidation Hair Dyes (Emulsion Type) [PCD19: Cosmetics]

IS 15205:2002

I~ (m*) –fi~l~

Indian Standard

OXIDATION HAIR DYES(EMULSION TYPE) — SPECIFICATION

ICS 71.100.70

0 BIS 2002

BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

September 2002 Price Group 4

l’!

Cosmetics Sectional Committee, PCD 19

FOREWORD

This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the CosmeticsSectional Committee had been approved by the Petroleum, Coal and Related Products Division Council.

Hair Dyes are cosmetic products intended for imparting colour to hair to produce varying shades. Hair dyes maybe broadly classified as liquid hair dyes and powder hair dyes. Liquid hair dyes maybe further classified into thefollowing types:

a) Oxidation hair dyes (liquid),

b) Oxidation hair dyes (emulsion type), and

c) Vegetable based hair dyes.

In the recent past, a number of oxidation hair dyes (emulsion types) have appeared in the Indian markets and itwas felt necessary to develop specification for this catego~ of dyeing preparation. The product being in emulsionform, this standard intends to include requiremenrlimits for fatty matter content in the preparation.

This specification covers only oxidation hair dyes (emulsion type) containing phenylene diamine and othercolorants as active ingredients. Modem hair dyes are commonly distinguished on the basis of duration up towhich their colour effect lasts. Broadly, dyes are sold in the market entitled as temporary, semi-permanent andpermanent hair dyes. Though, no time limit has been defined in this specification to categorize a dye to aparticular category.

The oxidation hair dyes (emulsion type) are frequently used as permanent hair colorants. Apart horn theirlong lasting nature, they differ from temporary and semi-permanent colours in two respects, namely, temporaryand semi-permanent colours use ready coloured dyes, which add to the existing colour of the hair. On the otherhand, oxidation hair dyes (emulsion type) contain an oil phase dispersed in water, the system stabilized with anemulsifying agent. These are oil-in-water type of preparations and contain ingredients that impart colour on thehair after being oxidized with atmospheric oxygen. Oxidation hair dyes (emulsion type) are single phase dyeswith no bleaching agent or developers like ammonia or hydrogen peroxide required to be supplied along withthe dye. The final colour can be darker than the original colour.

Oxidation hair dyes (emulsion type) work on the same principle of oxidation hair dyes (liquid) with a differencethat the oxygen required for the process of oxidation is not readily available in the form of a developer but ittakes oxygen from the atmosphere for the dyeing process. Since the process of oxidation is very slow, emulsiontype dyes require repeated applications on consecutive 2 to 3 days.

Furthermore, ideal properties of oxidation hair dyes have been listed in Annex A for guidance only. Some ofthese properties are presently not adequate for standardization, hence included for information only.

A scheme for labelling environment tliendly products known as ECO-Mark has been introduced at the instanceof the Ministry of Environment and Forests (MEF), Government of India. The ECO-Mark is being administeredby the Bureau of Indian Standards (BIS) under the BLS Act, 1986 as per the Resolution No.71 dated21 February 1991 and No.768 dated 24 August 1992,published in the Gazette of the Government of India. Fora product to be eligible for marking with ECO logo, it shall also carry the Standard Mark of BE3besidesmeeting additional environment friendly requirements. For this purpose, the Standard Mark of BIS would be asingle mark being a combination of the BIS monogram and the ECO logo. Requirements for ECO tilendlinesswiII be additional. Manufacturing units will be free to opt for Standard Mark alone also.

These requirements are included based on the Gazette Notification No. 170 dated 18 May 1996 for environmentfriendly products published in the Gazette of India.

The composition of the Committee responsible for formulation of this standard is given in Annex E.

For the purpose of deciding whether a particular requirement of this standard is complied with, the final value,observed or calculated, expressing the result of a test or analysis shall be rounded off in accordance with1S2: 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retained in therounded off value should be the same as that of the specified value in this standard.,

l“

IS 15205:2002

Indian Standard

OXIDATION HAIR DYES(EMULSION TYPE) – SPECIFICATION

1 SCOPE

1.1 This standard prescribes the requirement andmethod of sampling and test for oxidation hair dyes(emulsion type),

1.2 This Indian Standard does not cover oxidation hairdyes (liquid and cream), for which a separate standardIS 8481 exists.

2 REFERENCES

The following Indian Standards are necessary adjunctsto this standard. The standards contain provisions,which through reference in this text constitute provi-sions of this standard. At the time of publication, theeditions indicated were valid. All standards are subjectto revision, and parties to agreements based on thisstandard are encouraged to investigate the possibilityof applying the most recent editions of the standardsindicated below:

IS No.

1070:19923958:1984

4011:1997

4707

Part 1:2001

Part 2:2001

4730:1994

8481:2001

TitleReagent grade water (thirdrevision)Methods of sampling cosmetics (@frevision)Methods of test for safety evaluationof cosmetics (second revision)Classification of cosmetics raw mate-rials and adjuncts:Dyes, colours and pigments (secondrevision)List of raw materials generally notrecognized as safe for use in cosme-tics (second revision)Methods for determination of densityof liquids — Specification (firstrevision)Oxidation hair dyes liquid— Speci-fication (second revision)

3 TYPES

3.1 Oxidation hair dyes (emulsion type) are broadlyclassified in two categories depending upon the CO1OW,which they impart to the hair afier application of dye:

a) Type 1 — Black, and

b) Type 2 — Brown.

4 REQUIREMENTS

4.1 Description

These hair dyes (emulsion types) are ready for use

1

and slightly thick, light grey to bluish black viscousliquids.

4.2 Ingredients

Ingredients of dye shall comply with the provisions ofIS 4707 (Part 1) and IS 4707 (Part 2) subject to theprovisions of the Drugs and Cosmetics Act andRules, 1945.

4.3 Unless otherwise specified, all the raw materialsused in the manufacture of oxidation hair dyes(emulsion type) shall conform to the requirementprescribed in the relevant Indian Standards whereversuch standards exist.

4.4 Dye

The active ingredient may be an arylamine (para-phenylenediamine, PPD) dispersed in a suitablevehicle in an emulsion form. The brown coloured dyemay contain ortho or para amino phenol, etc, besidesarylamine, It may also contain suitable modifiers. Thedye shall comply with the requirements given inTable 1 when tested according to the method given inAnnex B to D and referred Indian Standard.

Table 1 Requirement for Dye

S1 Characteristic Requirement MethodofNo. Test, Ref to

A A

‘Type 1 Type ~ ‘Annex 1SNo,’Black Brown

(1) (2) (3) (4) (5) (6)i) pH 7t09 7t09 B

ii) Activematter as 2.0 to 4.0 Up to 3.0 CPPD contentper-cent by mass

iii) Total fatty matter, 8 8 Dpercent by mass,A-fin

iv) Density 0.90to 0.90to 47300.98 0.98

4.5 Additional Requirements for ECO-Mark

(Optional)

4.5.1 General Requirements

4.5.1.1 The product shall conform to the requirementsfor quality, safety and performance prescribedunder 4.5.1.2 to 4.5.1.5.

4.5.1.2 All the ingredients that go into formulation ofcosmetics shall comply with the provisions of IS 4707(Part 1) and IS 4707 (Part 2).The product shall also

IS 15205:2002

meet specific requirements rssgiven in the standard.

4.5.1.3 The product package shall display a list of keyingredients in descending order ofqttrtntity present.

4.5.1.4 The product shall not be manufactured fromany carcinogenic ingredients.

4.5.1.5 The manufacturer shall produce to BISenvironmental consent clearance from the concernedState Pollution Control Board as per the provisions ofthe Water (Prevention and Control of Pollution) CessAct, 1977 and the Air (Prevention and ControlPo/lution) Act, 1981 along with the authorization, ifrequired under the Environment (Protection) Act, 1986and the Rules made thereunder, while applying forECO-Mark. Additionally, provisions of the Drugs andCosmetics Act, 1940 and the Rules thereunder shallalso be complied with.

4.6 Specific Requirements

4.6.1 Heavy metals calculated as lead (Pb) and arsenic(As,OJ shall not exceed 20 and 2 ppm, respectivelywhen tested by the respective method prescribed inIndian Standards.

5 PACKING AND MARKING

5.1 Packing

The dye shall be filled in an amber coloured glassbottle properly capped or any other suitable containerlike collapsible plastic tubes, etc. The bottles/collap-sible tubeslother suitable container of dye and thecarton shall be suitably Iabelled.

5.2 Storage

The material shall be stored in a cool, dark place.

5.3 Marking

Each container (pouch/glass bottles, etc) and thepackage (carton/box) containing the same shall bemarked with the following information:

a)

b)

c)

d)

e)

od

Name of the material;

Identification of the source of mamrfactur~

Warning ‘shall not be used for dyeingeyelashes or eyebrows’;

Declaration ‘rtrylarnirte(p-phenylenediamirte)not more than 4 percent for Type 1 and notmore than 3 percent for Type 2;

Net content;

Shade of dye;

The words, ‘For best results use before ....*’(*month and year to be given);NOTE — This is exempted in case of pack sizes of 10gor 25 ml or less and if the shelf 1ifeof the product is morethan 24 months.

h)

j)

List of key ingredients; andNOTE—This is exempted in cq.$eof pack sizes of 30 g/60 ml or less.

Any other information required by statutoryauthorities.

In addition to the above, the following informationshall also be given in the attached leaflet:

a) Procedure for conducting preliminary test forsensitivity (patch test), and

b) Instructions for use.

5.3.1 BIS Certification Marking

The containers may also be marked with StandardMark.

5.3.1.1 The use of the Standard Mark is governed bythe provisions of Bureau ofIndian Standards Act, 1986and the Rules and Regulations made thereunder. Thedetails of conditions under which the Iicence for theuse of Standard Mark maybe granted to manufacturersor producers may be obtained from the Bureau ofIndian Standards.

5.4 Caution

p-Phenylenediamine (PPD) may cause skin irritationin certain cases, so a preliminary test according to theaccompanying direction should first be made (see5.4.1). The material shall not be used for dyeing theeyelashes or eyebrows as its use may cause blindness.

5.4.1 Each package shall contain instructions inEnglish and local languages on the following linesfor carrying out the test:

‘p-Phenylenediamine containing preparations maycause serious inflammation of the skin in somecases and so a preliminary test should always becarried out to determine whether or not specialsensitivity exists. For carrying out zthe test, cleansea small area of skin behind the ear or upon theinner surface of the forearm, using either soap andwater or alcohol, Apply a small quantity of the hairdye as used and allow it to dry. After 24 h, washthe area gently with soap and water. If no irritationor inflammation is apparent, it may be assumedthat no hypersensitivity to the dye exists. The testshould, however, be carried out before each andevery application. This preparation should on noaccount be used for dyeing eyebrows or eyelashesas severe inflammation of the eye or even blindnessmay result’.

6 SAMPLING

6.1 Representative samples of the material shall bedrawn as prescribed in IS ‘3958.

L

IS 15205:2002 $

6.2 Test for all the requirements shall be carried outon a composite sample.

6.3 The oxidation hair dyes, emulsion type preparationshall be taken to have conformed to this specificationif the composite sample passes all the tests.

7 TEST METHODS

Test for the requirements listed under 4 and Table 1shall be carried out according to methods prescribed

1)

2)

3)

$in Annex B to D and referred Indian Standard as

1/

mentioned under CO15and 6 of Table 1. b

8 QUALITY OF REAGENTS

Unless specified otherwise, pure chemicals anddistilled water (see IS 1070) shall be used in tests.

[NOTE — ‘Pure chemicals’ shallmeanchemicals that do not

“.

contain impurities which tiect the results of analysis.

ANNEX A

(Foreword)

IDEAL PROPERTIES OF OXIDATION HAIR DYE (EMULSION TYPE)

When seen visually oxidation hair dye(emulsion) shall be homogeneous and

4)

uniform. There should not be any sign ofseparation. It shall be thick and viscous butmust be easily pourable.

Must impart the desired colour on hair for a5)

longer duration. 6)

When applied on hair, it must spread easilyand disperse quickly over the hair.

Hair dye after application should rinse outeasily and should not have any residualtackiness and should not affect the texture ofhair.

Dye should have an agreeable odour/perfume.

The product should have good stability forthe period as declared by the manufacturer.

ANNEX B

[Table 1, SliVo. (i)]

DETERMINATION OF pH

B-1 APPARATUS B-2 PROCEDURE

A pH meter, preferably equipped with glass electrode. Take 50 ml of the dye and determine itspH at 27 * 2°Cusing pH meter.

3

IS 15205:2002

ANNEX C

[Table 1, SliVoo (ii)]

DETERMINATION OF ARYLAMINE CONTENT

C-1 REAGENTS

C-1. 1 Sodium Hypochlorite Solution — 5 percent(available chlorine NLT 3.5 percent).

C-1.2 Sodium Arsenite Solution — 10 percent,dissolve 10 g of sodium arsenite (reagent grade) in100 ml of water or dissolve by heating 8.5 g of arsenousoxide and 1.5 g of sodium hydroxide in 100 ml water.

C-1.3 Sodium Carbonate

C-1.4 Chloroform

C-1.5 Potassium Iodide

C-1.6 Hydrochloric Acid Concentrated —38 percent (w/v).

C-1.7 Sodium Thiosulphate Solution — 0.1 N,

C-1.8 Starch Solution

Triturate 5 g of starch, add 0.01 g of mercuric iodidein 30 ml of cold water and slowly pour it with stirringinto one litre of boiling water. Boil for 3 rein, allow tocool and decant off the supematant liquid for test.

C-2 PROCEDURE

C-2. 1 Preparation of Sample Solution

Weigh accurately about 10 g of dye sample and diluteto 250 ml using water in a standard volumetric flasksuch that 10 ml of the solution contains about 0.01 gof paraphenylenediamine.

C-2.2 Add to a separating funnel containing 5 ml ofsodium hypochlorite solution and 1 g of sodiumcarbonate, 10 ml of the sample solution. Gently swirl

the separating funnel during addition so that thesolution is thoroughly mixed (insufficient sodiumhypochlorite is indicated by the presence of browncolour). If brown colour appears, repeat the operationby using larger quantity of sodium hypochlorite.Stopper the separating timnel and shake for 10s. Add10 ml of sodium arsenite solution, stopper and shakeagain.

C-2.3 Extract the dichlorimide with two 25 ml portionsof chloroform and collect combined extracts in asecond separating timnel. Wash the extracts with two10 ml portions of water and transfer into an iodineflask. Make additional chloroform extractions, ifnecessary, wash with water and combine with themajor portion (any emulsion formed during extractionmay be broken by adding a few drops ofdcohol), Add50 ml of water containing lg of potassium iodide and3 ml of hydrochloric acid to the iodine flask. Stopperthe flask and shake vigorously at intervals duringtitration. The iodine in the chloroform acts as anindicator. Towards the end of the titration, add starchsolution for final end point.

C-3 CALCULATION

Total active matter (dye content), = 45.o5 x v x Npercent by mass M

where

v=

N=

M=

volume of sodium thiosulphate requiredto titrate 10 ml of sample solution,

normality of sodium thiosulphate solution,and

mass of dye taken to prepare 250 ml ofsample solution,

ANNEX D

[Table 1, SINO. (iii)]

DETERMINATION OF TOTAL FATTY SUBSTANCES

D-1 PRINCIPLE OF THE METHOD

The emulsion is broken with a dilute mineral acidand fatty matter is extracted with petroleum ether orethyl ether. It is weighed after removal of the solvent.

D-2 REAGENTS

D-2.1 Dilute Hydrochloric Acid 1:1 (v/v)

D-2.2 Ethyl Ether (40 to 60°C) or Petroleum Ether(60 to 80°C)

4

IS 15205:2002

D-2.3 Methyl Orange Indicator Solution — Dissolve0.1 gofmethyl orange inlOOml of water.

D-2.4 Sodium Sulphate Anhydrous

D-3 PROCEDURE

Weigh accurately about 4 to 5 g of the material htothe conical flask, add 25 ml dilute hydrochloric acid,fit a reflux condenser into the flask, boiI the contentsuntil the solution is perfectly clear. Pour the contentsof the flask into a 300 ml separating funnel and allowit to cool to 20°C, Rinse the conical flask with ethylether in portions of 10 ml. Pour the ether rinsingsinto the separating fimnel. Shake the separating funnelwell and leave until the layers separate. Separate outthe aqueous phase and shake it out with 50 ml of ethertwice. Combine all the ether extracts and wash themwith water until free of acid (when tested with methylorange indicator solution),

Filter the ether extracts through filter paper containingsodium sulphate into a conical flask, which has beenpreviously dried at a temperature of 105 + 2°C andthen weigh. Wash the sodium sulphate on the filterwith ether and combine the washings with filtrate.Distil off the ether and dry the material remaining inthe flask at a temperature of 105 + 2°c to amstantmass.

D-4 CALCULATION

Total fatty substance,

percent by mass = 100 #2

where

Ml = mass in gram of the residue, and

IUz = mass in gram of the sample taken for thetest.

5

IS 15205:2002

ANNEX E

(J’orewo@

COMMITTEE COMPOSITION

Cosmetics Sectional Committee, PCD 19

Organization

Directorate General ofJieakh Services,New Delhi

All India Small Scale Cosmetic Manufacturer’sAssociation,Mumbai

Bengal Chemicals &Pharmaceuticals Ltd, Kolkata

Central Drugs Laboratory, Kolkata

Central India PharmacopaeiaLaboratory,Ghaziabad

Consumer Education and ResearchCentre,Ahmedabad

Consumer Guidance Society, Mumbai

Colgate-Palmolive (India)Ltd, Mumbai

Commissioner, Food & DrugsAdministration,Mumbai

Dabur Research Foundation, Sahibabad (UP)

Food & DrugsControl Administration, Gujarat State, Garsdhinagar

Godrej Soaps Ltd, Mumbai

Hindustan Lever Research Centrc, Mumbai

Hygienic Research Institute,Mumbai

Indian Soaps and Toiletries Members’Association,Mumbai

Johnson &Johnson Ltd, Mumbai

Lady IrwinCollege, New Delhi

Lady Amritbai Doga College, Nagpur

Maharishi Ayurved Products, Noida (UP)

Nahira Cosmetic Enterprises Pvt Ltd, Mumbai

National Test House, KoUmta

Procter& Gamble, Mumbai

Shingar Ltd, Mumbai

Representative(s)

sHRIAsHwrNrKuiuAa(chsirtnan)

SsauM. B. DsmrSmu B. M. CHoPtu (Alternate 1)SHSUs.cHmrERm(Alfernate H)

Drt!WWK. ROYCHOWTHJRY

DtrA. K. A4AmM.(Alternate)

DstM.K.~sxDR A. C. DASGUPTA(Alternate)

DRsANrosH.K.TMWM

Da SUSCOMALDAS(Alternate)

DRC.J. SsmrmoSr+ruY.S. Yrmuuts(Aftertrate)

SmuN. G. WAW

DRS.G.BHAT(Alternate)

DRRAIKoHLlSmu Surva.Acxaawti(Alternate 1)DtLNSENAS~ (Alternate II)

DRPu”WWst

DRD.B.A.NARAYANA

DstP.J. TmmsSmuJ. J. Sr+uru (Alferrrate)

SmuA.IWWMllst (Smmrm) RormvTrwam (Alternate)

DRPUXHKERSONASrrruN.SBrmma(Alternate1)Mu Cvru.mDW (Alternate 11)

SsmrM. B. Ds.msSrrrahLwmwrK.C-W (Alternate)

Srauv.P.Mmcm

DRPRAmANrAaHYANKARDaV. R. Bwurouw(Altemate)

The Prhcipsd

IX Srsstwm S.B. Kuuurmr

DRS.C. SAXEhASmrrV.K.SHRIVMrAVA(Alternate)

Smlkh05WURy. BOSDAWIKAR

WattG.J. Lm (A[ternate)

SmaK.C.NrmwDp.S.K. !%m (Alternate)

hARONvISWANATH

Wramn %mvErAponANOAaE(Aherna@

SmaV. K. Sm@SmuwvrtVmw Bratm(Alternate)

(Continued on page 7)

6

IS 15205:2002

(Confinuedfranr page 6)

Organization Represenk?tive(s)

ShriramInstitute forIndustrialResearch,NewDelhi SSSSUS.K.CrrnrDRU. C. BAMU(Alrernafe)

In personrdcapacity (B-22, Manish Complex No. 10, Convenr Road, DRS. N.lVER

Bangalore 560021)

BIS DirectorateGeneral SmuANJANKAR,Dkector & Head(PCD)@eprsentingDirectorGeneral (I&q77cio)]

Member Secreta~DR(%RR4ATI)VUAYMALJK

Director (PCD),BIS

Hair Care Products Subcommittee, PCD 19:2

Godrej Soaps Ltd, Mumbai

BengalChemicals &Pharmaceuticals Ltd, Kolkata

Cavin KareLtd, Chennrd

ConsumerGuidanceSwSety,Mumbai

Food & DrugsAdministration,Mumbai

Food & DrugsControl Adrnn,(lmlhinagar

GeoffreyManners &Co Ltd, Mumbai

HindustanLever ResearchCentre,Mumbai

HeenaExportsCorporation,Faridabad

HygienicResearchInstifute,Mrnnbai

ImpressionCosmetics,Faridabad

Johnson&Johnson Ltd Mumbai

Marico IndustriesLtd, Mumbai

Micky Products,Faridabad

Procter&Gamble India Ltd, Mumbai

ShrirarnInstitute for Industrial Research,New Delhi

In personal capacity (B-22,Munish Complex No. 10, Canvent Road,Bangalore 560021)

DR(SrauM@ ROHSNSTHAKRAR(Convener)SrnuA. RANGARAJAN(Alternate)

DRS. CHASWRORN

DRA. K. MANUAL(Alternate)

Sssslv.RAM4suBRmANlANSHIU S. GANESH(Alternate)

SHRIN.G. WAGLE

DRPUANXAR

SHRIMATSR.B. DESAISmuG.J. PAT’EZ(Alternate)

SHRSB.D. KALESmrrM.V. BrrLSW(Alternate)

f)Rs. RAGM.PATl

DRPUSHKARSONA(Alternate)

SHSUJ.P. GUETA

SsmrM. B. DESASSsrruM. K. CHRASSRA(Alternate)

%R3h4ATt%4SHt&A

%sroM. K. GUPTA(Alternate)

DRASSTM.ANXE

DRV.R. Bmmwmwsr(Alternate)

SHRIR.B. MOMLE

SHRSMANOIKUTWW

f)RANJNvISWANATH

St-area’nSmA PURANOARE(Alternate)

SHRIK.M. CHACKO

SmrrA. K.GUPTA(Alterna@

DR S. N. IVER

7

1’;1’

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to comected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free use, in the course ofimplementing the standard, of necessary details, such as symbols and sizes, type m grade designations.Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments, Standards are also reviewedperiodically; a standard along with amendments is reat%rmed when such review indicates that no changes areneeded; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standardsshould ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed horn Doc : No. PCD 19 (1735)

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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